Neoadjuvant Immunochemotherapy vs Chemoradiotherapy in ESCC

NCT ID: NCT07236320

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2025-02-28

Brief Summary

This retrospective real-world study aimed to compare neoadjuvant immunochemotherapy (NICT) and neoadjuvant chemoradiotherapy (NCRT) followed by esophagectomy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). A total of 203 consecutive patients treated at Sichuan Cancer Hospital between March 2018 and March 2022 were analyzed (NICT: 59; NCRT: 144). The primary endpoints were overall survival (OS) and disease-free survival (DFS); secondary endpoints included pathological complete response (pCR), tumor regression grade (TRG), and R0 resection rate. After inverse probability of treatment weighting adjustment, baseline characteristics were balanced between groups. Both groups achieved comparable long-term OS and DFS, while NCRT showed higher rates of local pathological response. Exploratory subgroup analysis suggested that patients achieving pCR after NICT might have superior survival outcomes. The study indicates that NICT provides similar long-term survival compared to NCRT and may offer immunologic advantages for selected responders, warranting further validation in prospective multicenter trials.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NICT group

Group Type: EXPERIMENTAL

Neoadjuvant immunochemotherapy

Intervention Type: DRUG

NACI group patients received treatment of minimally 2 cycles of ICIs agent (mainly camrelizumab or toripalimab, 200 mg every 3 weeks (200 mg every 3 weeks)) combined with concurrent chemotherapy.

NCRT group

Group Type: ACTIVE_COMPARATOR

Neoadjuvant Chemoradiotherapy

Intervention Type: DRUG

NCRT group patients followed the concurrent NCRT treatment, and the total neoadjuvant radiotherapy dose was 40.0-50.4Gy with 1.8-2.14 Gy fractions and 5 fractions/week.

Interventions

Neoadjuvant immunochemotherapy

NACI group patients received treatment of minimally 2 cycles of ICIs agent (mainly camrelizumab or toripalimab, 200 mg every 3 weeks (200 mg every 3 weeks)) combined with concurrent chemotherapy.

Intervention Type: DRUG

Neoadjuvant Chemoradiotherapy

NCRT group patients followed the concurrent NCRT treatment, and the total neoadjuvant radiotherapy dose was 40.0-50.4Gy with 1.8-2.14 Gy fractions and 5 fractions/week.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-80 years
• Histologically confirmed thoracic ESCC
• Clinical stage cT1N+M0 or cT2-4aN0-3M0
• Received neoadjuvant therapy (immunochemotherapy or chemoradiotherapy) followed by esophagectomy

Exclusion Criteria

• History of other malignancies
• Did not complete neoadjuvant therapy or required salvage surgery
• Incomplete baseline or follow-up data

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yongtao Han

OTHER

Sponsor Role: lead

Responsible Party

Yongtao Han

Chief Surgeon / Professor, Department of Thoracic Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, China

Countries

China

Other Identifiers

SCCH-TS2503

Identifier Type: -

Identifier Source: org_study_id